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| Sponsor: | Cytran |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002445 |
Purpose
The purpose of this study is to see if it is safe and effective to use IM862 to treat Kaposi's sarcoma (KS) in AIDS patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma, Kaposi HIV Infections |
Drug: IM862 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | A Phase III Randomized Placebo Controlled and Double Blinded Study of IM862 for Patients With Muco-Cutaneous AIDS Associated Kaposi's Sarcoma |
| Estimated Enrollment: | 200 |
Patients are stratified by CD4 count, viral load, and prior systemic chemotherapy. Patients are randomized equally to receive either IM862 or placebo given intranasally every other day. Patients are seen every 4 weeks for 6 months or until disease progression to evaluate toxicity and efficacy. Quality of life is assessed before treatment, then every month for 6 months. At the end of the 6-month study evaluation period, patients with PR/CR (responders) remain on study and continue blinded treatment for an additional 6 months. For patients with stable disease (non-responders), the treatment assignment is unblinded and off-study IM862 compassionate use is offered for 6 months, regardless of treatment group. For patients with documented progressive disease (treatment failure), the treatment assignment is unblinded and off-study IM862 is offered for 6 months to any patient in the placebo group. For treatment failures in the IM862 group, IM862 is stopped and the patient is allowed other therapy options.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Contacts and Locations
Show 42 Study Locations| Study Chair: | Parkash Gill | |
| Study Chair: | David Scadden | |
| Study Chair: | Ariela Noy |
More Information
| Study ID Numbers: | 306A, KS-20898-01, AMC-013 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002445 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Placebos Sarcoma, Kaposi |
Antineoplastic Agents Treatment Outcome Quality of Life |
|
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Neoplasms by Histologic Type Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Infection Immunologic Deficiency Syndromes Herpesviridae Infections |
Virus Diseases Neoplasms, Connective and Soft Tissue Neoplasms HIV Infections Sexually Transmitted Diseases Neoplasms, Vascular Tissue Sarcoma Lentivirus Infections DNA Virus Infections Retroviridae Infections |